N
Patient 1
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SENT UPON CONCLUSION.
MAUDE MDR 6431605
- MDR report key
- 6431605
- Report number
- 1820334-2017-00496
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-01-25
- Date received
- 2017-03-24
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. RITA HARDEN
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-03-24 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING A GOLDSTEIN SONOHYSTEROGRAPHY CATHETER. THE REPORTER INDICATED THE PROCEDURE WENT AS INTENDED, HOWEVER PRIOR TO REMOVING THE SPECULUM IT WAS NOTED THAT THE STOPPER HAD SEPARATED. THE ATTENDING PHYSICIAN WAS ABLE TO RETRIEVE THE STOPPER AND THERE WERE NO UNINTENDED SECTIONS OF THE DEVICE THAT REMAINED INSIDE OF THE PATIENT?S BODY, NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.
N
Patient 1
INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE COMPLAINT DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE IS SHIPPED WITH AN IFU THAT DESCRIBES, ?UPON REMOVAL OF CATHETER, ENSURE THAT POSITIONER IS STILL ON BODY OF THE CATHETER. IF STILL LODGED IN PATIENT CERVIX, REMOVE USING FORCEPS.? THIS IS NOT A MALFUNCTION OF THE DEVICE. THE POSITIONER (CONE) IS DESIGNED TO BE MOVEABLE IN ORDER TO PLACE ONLY THE TIP OF THE CATHETER INSIDE OF THE UTERUS. THE IFU STATES: CATHETER IS REMOVED UPON COMPLETION OF ULTRASOUND PROCEDURE. NOTE: UPON REMOVAL OF CATHETER, ENSURE THAT POSITIONER IS STILL ON THE BODY OF THE CATHETER. IF LODGED IN PATIENT CERVIX, REMOVE USING FORCEPS. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; WITHOUT THE PRODUCT, THE FAILURE CANNOT BE INVESTIGATED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED TO FAILURE MODE CONTRIBUTED TO THIS EVENT. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. WITHOUT THE LOT NUMBER, NON-CONFORMANCES REVIEW AND ADDITIONAL COMPLAINT LOOKUP CANNOT BE COMPLETED. BASED ON THE PROVIDED INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED OR REPORTED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.